[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58326-58328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

Project: Fetal Alcohol Spectrum Disorders (FASD) Center for Excellence 
(CFE) Screening and Brief Intervention (SBI) Project and Project 
CHOICES Evaluation (OMB No. 0930-0302)--Reinstatement

    Since 2001, SAMHSA's Center for Substance Abuse Prevention has been 
operating the SAMHSA Fetal Alcohol Spectrum Disorders (FASD) Center for 
Excellence (CFE). The purpose of the FASD Center for Excellence is to 
prevent alcohol-exposed pregnancies among women of childbearing age and 
pregnant women and to improve the quality of life for individuals 
affected by FASD. Data will be collected from women served across 
approximately 10 sites in local/community-based agencies. Women will be 
screened for alcohol use, and provided appropriate interventions based 
on their pregnancy status.
    The FASD CFE will be integrating Screening and Brief Intervention 
(SBI) for pregnant women and Project CHOICES for non-pregnant women 
through service delivery organizations and will monitor the results. 
Approximately 10 sites will implement the SBI program and/or Project 
CHOICES.
    At baseline, an assessment form will be administered by the 
counselor to screen women at the participating sites or health care 
delivery programs. Basic demographic data will be collected for all 
women screened (age, race/ethnicity, education, and marital status) at 
baseline by participating sites but no personal identification 
information will be transmitted to SAMHSA. Both quantity and frequency 
of drinking will be assessed for all women. Pregnant women will be 
assessed for risk of alcohol use using the TWEAK screening instrument, 
which has been used successfully with pregnant women. Non-pregnant 
women will be assessed for ability to conceive and use of effective 
birth control.
    SBI focuses on 10- to 15-minute counseling sessions, conducted by a 
counselor who will use a scripted manual to guide the program. 
Participants in SBI will be assessed throughout their pregnancy to 
monitor

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alcohol use, referred for additional services to support their efforts 
to stop drinking, and will be provided with the 10-15 minute program 
until the client abstains from alcohol. Clients will be followed up 
until their 36th week of pregnancy. At each process visit, the quantity 
and frequency of drinking will be assessed and the client's goals for 
drinking will be recorded. In addition, process level variables will be 
assessed to understand how the program is being implemented (e.g., 
whether SBI was delivered; duration of the program; what referrals were 
made; client satisfaction). At the 36th week of pregnancy quantity and 
frequency of drinking will be assessed, and the client's satisfaction 
with the program will be recorded.
    For those who screen positive for Project CHOICES (non-pregnant 
women 18-44 years who are at risk for an alcohol-exposed pregnancy), 
the program will provide two Motivational Interviewing (MI) sessions 
related to alcohol use, plus one contraceptive counseling session. The 
goal is to help these women prevent an alcohol-exposed pregnancy by 
abstaining from alcohol and using contraceptive methods of their choice 
consistently and correctly. At the end of the Project CHOICES program, 
women are assessed on their alcohol consumption and contraceptive use 
in the past 30 days, and their satisfaction with the program is 
recorded. At 3 months and 6 months after the end of the program, women 
are assessed on 30-day alcohol consumption and contraceptive use using 
the same core assessment form that was used at baseline.
    All participating sites will maintain personally identifiable 
information of their clients for service delivery purposes, but the 
sites will keep such information private to the maximum extent 
allowable by laws. Data will be collected at the site level and sites 
will be instructed to keep personal data secure in a specified 
location. To further ensure privacy of individual responses, all data 
will be reported at the aggregate level so that individual responses 
cannot be identified; no data will be reported at the individual 
participant level. Furthermore, data will be collected to meet the 
criteria of a ``limited data set'' as defined in the Privacy 
Regulations issued under the Health Insurance Portability and 
Accountability Act (HIPAA), (HIPAA Privacy Rule, 45 CFR --164.501) [45 
CFR 164.514(e)(4)(ii)]. A computer generated coding system will be used 
to identify the records, and access to records will be limited only to 
authorized personnel. In addition, the identifiers will be stored 
separately from the data. No direct identifiers will be included in 
order for the data to be considered a ``limited data set.'' A summary 
of the actions the contractors will take in order to comply with HIPAA 
follows:
     Ensure that the personal health information respondents 
disclose to outside entities does not violate the Privacy Rule.
     When creating a unique identification code, ensure that 
the code does not contain information that can be used to identify the 
individual.
     Sign a data agreement that states all HIPAA requirements 
will be adhered to consistent with a limited data set.
     Agree to maintain the confidentiality of alcohol and drug 
abuse client records according to the provisions of Title 42 of the 
Code of Federal Regulations, Part II.
    The data collection is designed to monitor the implementation of 
the proposed programs by measuring whether abstinence from alcohol is 
achieved, and for Project CHOICES by measuring whether effective birth 
control practices are performed. Furthermore, the program will include 
process measures to monitor how the interventions were provided.

                                        Estimated Annualized Burden Hours
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                                                     Number of                        Average      Total burden
       Instrument/activity           Number of     responses per   Total number     burden per       hours per
                                    respondents     respondent     of responses      response       collection
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                                              Pregnant Women (SBI)
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Baseline Assessment (Form A)....           9,273               1           9,273             .25           2,318
Process Assessment for all                 2,468               2           4,936             .21           1,037
 Eligible women.................
(Forms A and B).................
(26.6% of baseline).............
Process Assessment for women                 395               1             395             .21              83
 actively drinking..............
(Forms A and B).................
(16% of 2,468 eligible women)...
End of Program Assessment (Forms           1,234               1           1,234             .16             197
 A and C).......................
(50% of eligible women).........
                                 -------------------------------------------------------------------------------
    SBI Sub Total...............           9,273  ..............          15,838  ..............           3,635
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                                      Non-Pregnant Women (Project CHOICES)
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Baseline Assessment (Form A)....           1,220               1           1,220             .25             305
End of program Assessment (Forms             314               1             314             .25              79
 A and C).......................
(50% of 629 eligible women).....
Follow-up Assessment............             314               2             628             .25             157
(Form A)........................
(50% of 629 eligible women).....
                                 -------------------------------------------------------------------------------
    Project CHOICES Sub Total...           1,220  ..............           2,162  ..............             541
                                 -------------------------------------------------------------------------------
        Totals..................          10,493  ..............          18,000  ..............           4,176
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    Written comments and recommendations concerning the proposed 
information collection should be sent by October 23, 2013 to the SAMHSA 
Desk Officer at the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB). To ensure timely receipt of 
comments, and to avoid potential delays

[[Page 58328]]

in OMB's receipt and processing of mail sent through the U.S. Postal 
Service, commenters are encouraged to submit their comments to OMB via 
email to: [email protected]. Although commenters are 
encouraged to send their comments via email, commenters may also fax 
their comments to: 202-395-7285. Commenters may also mail them to: 
Office of Management and Budget, Office of Information and Regulatory 
Affairs, New Executive Office Building, Room 10102, Washington, DC 
20503.

Summer King,
Statistician.
[FR Doc. 2013-22958 Filed 9-20-13; 8:45 am]
BILLING CODE 4162-20-P